Deferasirox Vivanta 360 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Deferasirox Vivanta 360mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you or your child and must not be given to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Deferasirox Vivanta is and what it is used for
2. What you need to know before taking Deferasirox Vivanta
3. How to take Deferasirox Vivanta
4. Possible side effects
5. How to store Deferasirox Vivanta
6. Contents of the pack and other information

1. What Deferasirox Vivanta is and what it is used for

What Deferasirox Vivanta is

Deferasirox Vivanta contains an active substance called deferasirox. It is an iron chelator, a type of medicine used to remove excess iron from the body (also known as iron overload). It binds and removes excess iron, which is then excreted mainly in the faeces.

What Deferasirox Vivanta is used for

Repeated blood transfusions may be necessary for patients with various types of anaemia (e.g. thalassaemia, sickle cell anaemia or myelodysplastic syndromes (MDS)). However, repeated blood transfusions can lead to an accumulation of excess iron. This is because blood contains iron, and the body has no natural way of eliminating the excess iron received through blood transfusions. In patients with non-transfusion-dependent thalassaemia syndromes, iron overload may also develop over time, primarily due to increased absorption of dietary iron in response to low blood cell counts. Over time, excess iron can damage important organs such as the liver and heart. Medicines known as iron chelators are used to remove excess iron and reduce the risk of organ damage.

Deferasirox is used to treat chronic iron overload caused by frequent blood transfusions in patients with beta-thalassaemia major who are 6 years of age and older.

Deferasirox is also used to treat chronic iron overload when treatment with deferoxamine is contraindicated or not suitable in patients with beta-thalassaemia major who have iron overload due to infrequent blood transfusions, in patients with other types of anaemias, and in children aged 2 to 5 years.

Deferasirox is also used to treat patients aged 10 years and older who have iron overload associated with thalassaemia syndromes but who are not transfusion-dependent, when treatment with deferoxamine is contraindicated or not suitable.

2. What you need to know before taking Deferasirox Vivanta

Do not take Deferasirox Vivanta

• if you are allergic to deferasirox or to any of the other ingredients of this medicine (listed in section 6). If this applies to you, inform your doctor before taking Deferasirox. If you think you may be allergic, consult your doctor.
• if you have moderate or severe kidney disease.
• if you are currently taking any other iron-chelating medicine.

Deferasirox Vivanta is not recommended

• if you have advanced myelodysplastic syndrome (MDS, reduced production of blood cells by the bone marrow) or advanced cancer.

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with Deferasirox.

• if you have kidney or liver problems.
• if you have heart problems due to iron overload.
• if you notice a marked decrease in the amount of urine you pass (a sign of kidney problems).
• if you develop a severe rash, or have difficulty breathing, dizziness, or swelling mainly of the face and throat (signs of a severe allergic reaction; see also section 4, "Possible side effects").
• if you experience a combination of any of the following symptoms: rash, skin redness, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, swollen lymph nodes (signs of a severe skin reaction; see also section 4, "Possible side effects").
• if you notice a combination of drowsiness, pain in the upper right part of the abdomen, yellowing or increased yellowing of the skin or eyes, and dark-colored urine (signs of liver problems).
• if you notice difficulty thinking, remembering information, or solving problems, or if you are less alert or awake, or feel drowsy and weak (signs of high blood ammonia levels, which may be associated with liver or kidney problems; see also section 4, "Possible side effects").
• if you have vomiting with blood and/or black stools.
• if you have frequent abdominal pain, particularly after eating or taking deferasirox.
• if you have frequent heartburn.
• if you have low platelet or white blood cell counts in your blood test.
• if you have blurred vision.
• if you have diarrhea or vomiting.

If you are in any of these situations, inform your doctor immediately.

Monitoring your treatment with Deferasirox Vivanta

During treatment, you will have regular blood and urine tests. These tests will monitor the amount of iron in your body (blood ferritin levels) to assess how well deferasirox is working. The tests will also monitor kidney function (blood creatinine levels, presence of protein in urine) and liver function (blood transaminase levels). Your doctor may request a kidney biopsy if significant kidney damage is suspected. You may also undergo MRI (magnetic resonance imaging) tests to determine the amount of iron in your liver. Your doctor will use the results of these tests to determine the most appropriate dose of Deferasirox Vivanta for you, and to decide when your treatment with Deferasirox should be stopped.

As a precaution, your vision and hearing will be checked annually during treatment.

Other medicines and Deferasirox Vivanta

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes in particular:

• other iron chelators – these must not be taken with deferasirox,
• antacids (medicines used to treat heartburn) containing aluminium – these must not be taken at the same time of day as Deferasirox,
• ciclosporin (used to prevent organ transplant rejection or for other conditions such as rheumatoid arthritis or atopic dermatitis),
• simvastatin (used to lower cholesterol levels),
• certain painkillers or anti-inflammatory medicines (e.g. aspirin, ibuprofen, corticosteroids),
• oral bisphosphonates (used to treat osteoporosis),
• anticoagulant medicines (used to prevent or treat blood clots),
• hormonal contraceptives (medicines for birth control),
• bepridil, ergotamine (used for heart problems and migraines),
• repaglinide (used to treat diabetes),
• rifampicin (used to treat tuberculosis),
• phenytoin, phenobarbital, carbamazepine (used to treat epilepsy),
• ritonavir (used for the treatment of HIV infection),
• paclitaxel (used for cancer treatment),
• theophylline (used to treat respiratory diseases such as asthma),
• clozapine (used to treat psychiatric disorders such as schizophrenia),
• tizanidine (used as a muscle relaxant),
• colestyramine (used to reduce blood cholesterol levels),
• busulfan (used as pre-transplant treatment to destroy the original bone marrow before transplant),
• midazolam (used to relieve anxiety and/or sleep disturbances).

Additional tests may be needed to monitor blood levels of some of these medicines.

Elderly (aged 65 years and over)

Deferasirox can be used by people aged 65 years and over at the same dose as other adults. Elderly patients may experience more side effects (especially diarrhea) than younger patients. Your doctor should closely monitor for side effects that may require dose adjustment.

Children and adolescents

Deferasirox can be used in children and adolescents aged 2 years and older who receive regular blood transfusions, and in children and adolescents aged 10 years and older who do not receive regular blood transfusions. As the patient grows, the doctor will adjust the dose accordingly.

Deferasirox is not recommended in children under 2 years of age.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Treatment with deferasirox is not recommended during pregnancy unless clearly necessary.

If you are currently using hormonal contraception to prevent pregnancy, you should use an additional or different contraceptive method (e.g. condom), as Deferasirox may reduce the effectiveness of hormonal contraceptives.

Breastfeeding is not recommended during treatment with Deferasirox.

Driving and using machines

If you feel dizzy after taking deferasirox, do not drive or operate tools or machinery until you feel normal again.

Deferasirox Vivanta contains lactose and sodium.

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Deferasirox Vivanta

Treatment with deferasirox will be supervised by a physician experienced in the management of iron overload due to blood transfusions.

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

How much deferasirox you should take

The dose of deferasirox is based on body weight for all patients. Your doctor will calculate the dose you require and will tell you how many film-coated tablets to take each day.

• The usual daily starting dose of deferasirox film-coated tablets for patients receiving regular blood transfusions is 14 mg per kilogram of body weight. Your doctor may recommend a higher or lower dose depending on your individual treatment needs.
• The usual daily starting dose of deferasirox film-coated tablets for patients not receiving regular blood transfusions is 7 mg per kilogram of body weight.
• Depending on your response to treatment, your doctor may later adjust your dose to a higher or lower level.
• The maximum recommended daily dose of deferasirox film-coated tablets is:
  • 28 mg per kilogram of body weight for patients receiving regular blood transfusions,
  • 14 mg per kilogram of body weight for adult patients not receiving regular blood transfusions,
  • 7 mg per kilogram of body weight for children and adolescents not receiving regular blood transfusions.

In some countries, deferasirox may also be available as dispersible tablets manufactured by other companies. If you are switching from these dispersible tablets to Deferasirox Vivanta film-coated tablets, your dose will change. Your doctor will calculate the required dose and inform you how many film-coated tablets to take each day.

When to take Deferasirox Vivanta

• Take deferasirox once daily, every day, at the same time, with a glass of water. Take deferasirox film-coated tablets on an empty stomach or with light meals.
• Taking deferasirox at the same time each day will also help you remember when to take your tablets.

Patients who have difficulty swallowing tablets may crush the deferasirox film-coated tablets and mix the powder with soft food such as yoghurt or apple puree (applesauce). The entire dose should be consumed immediately; do not save any for later use.

How long to take Deferasirox Vivanta

Continue taking deferasirox every day for as long as your doctor instructs. This is a long-term treatment, which may last for months or years. Your doctor will monitor your condition periodically to ensure the treatment is having the desired effect (see also section 2: "Monitoring your treatment with Deferasirox Vivanta").

If you have any doubts about how long you should take Deferasirox Vivanta, consult your doctor.

If you take more Deferasirox Vivanta than you should

If you have taken too much deferasirox, or if someone accidentally takes your tablets, contact your doctor or go to a hospital immediately. Show the doctor the tablet packaging. You may require urgent medical treatment. You may experience effects such as abdominal pain, diarrhoea, nausea and vomiting, and kidney or liver problems, which could be serious.

In case of overdose or accidental ingestion, go to a medical centre or call the Toxicology Information Service at: 91 562 04 20, stating the name of the medicine and the amount taken.

If you forget to take Deferasirox Vivanta

If you forget to take a dose, take it as soon as you remember on the same day. Take your next dose according to your usual schedule. Do not take a double dose the next day to make up for the missed dose(s).

If you stop taking Deferasirox Vivanta

Do not stop your treatment with deferasirox unless instructed by your doctor. If you stop taking it, excess iron will not be removed from your body (see also previous section "How long to take Deferasirox Vivanta").

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Most adverse effects are mild or moderate and usually disappear after a few days or weeks of treatment.

Some adverse effects may be serious and require immediate medical attention.

These adverse effects are uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people)

• If you develop a severe rash, or have difficulty breathing and dizziness or swelling, especially of the face and throat (signs of a severe allergic reaction),
• If you experience a combination of any of the following symptoms: rash, skin redness, blisters on lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, swollen lymph nodes (signs of a severe skin reaction),
• If you notice a marked decrease in urine volume (a sign of kidney problem),
• If you notice a combination of drowsiness, pain in the upper right part of the abdomen, yellowing or increased yellowing of the skin or eyes, and dark urine (signs of liver problems),
• If you notice difficulty thinking, remembering information, or solving problems, or are less alert or awake, or feel drowsy and weak (signs of high blood ammonia levels, which may be associated with liver or kidney problems and may cause changes in brain function),
• If you have vomiting with blood and/or black stools,
• If you have frequent abdominal pain, particularly after eating or taking deferasirox,
• If you have frequent heartburn,
• If you experience partial loss of vision,
• If you have severe pain in the upper part of the stomach (pancreatitis),

Stop taking the medicine and contact your doctor immediately.

Some adverse effects may become serious.

These adverse effects are uncommon

• If you have blurred vision,
• If you experience hearing loss,

inform your doctor as soon as possible.

Other adverse effects

Very common (may affect more than 1 in 10 people)

• Abnormalities in kidney function tests.

Common (may affect up to 1 in 10 people)

• Gastrointestinal disturbances such as nausea, vomiting, diarrhoea, abdominal pain,
  swelling, constipation, indigestion.

• Rash

• Headache

• Abnormalities in liver function tests

• Itching

• Abnormalities in urine tests (protein in urine)

If you experience any of these effects severely, inform your doctor.

Uncommon (may affect up to 1 in 100 people)

• Dizziness
• Fever
• Sore throat
• Swelling in arms and legs
• Changes in skin colour
• Anxiety
• Sleep disturbance
• Fatigue

If you experience any of these effects severely, inform your doctor.

Frequency not known (cannot be estimated from available data)

• Decrease in the number of cells involved in blood clotting (thrombocytopenia), decrease in red blood cells (worsening of anaemia), decrease in white blood cells (neutropenia), or decrease in all types of blood cells (pancytopenia)
• Hair loss
• Kidney stones
• Low urine output
• Rupture of the stomach or intestinal wall, which may be painful and cause nausea
• Severe pain in the upper part of the stomach (pancreatitis)
• Abnormal levels of acid in the blood

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Deferasirox Vivanta

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the blister after EXP and on the outer packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not use any pack that is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Deferasirox Vivanta

The active substance is deferasirox.

• Each film-coated tablet contains 360 mg of deferasirox.

The other components are:

Tablet core

Microcrystalline cellulose (E460); sodium croscarmellose; low-substituted hydroxypropyl cellulose (E463); poloxamer 188; povidone K30; lactose monohydrate; colloidal anhydrous silica (E551); sodium stearyl fumarate; hydrogenated castor oil.

Tablet coating

Opadry Yellow 03H520019 (HPMC 2910/Hypromellose (E464)), titanium dioxide (E171), propylene glycol (E1520), talc (E553b), yellow iron oxide (E172).

Appearance of Deferasirox Vivanta and contents of the pack

Film-coated yellow, oval tablets (approximately 17 mm x 7 mm), biconvex, bevelled edges, engraved with “D” on one side and “360” on the other.

Each blister contains 30, 90 or 300 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Prague 9

Czech Republic

Manufacturer responsible

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park,

Paola, PLA3000,

Malta

You can request further information about this medicinal product from the marketing authorization holder's local representative:

Local representative:

Mabo-Farma S.A.

Calle Vía de los Poblados 3, Edificio 6

28033 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

The Netherlands: Deferasirox Vivanta 360 mg
Germany: Deferasirox Vivanta 360 mg Filmtabletten
Spain: Deferasirox Vivanta 360 mg film-coated tablets EFG
Italy: Deferasirox Vivanta

Date of the most recent review of this leaflet: 11/2022

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.